Phase I trial of locoregional administration of autologous tumor-infiltrating lymphocytes in patients with uveal melanoma and liver metastases (the HAITILS trial) - PubMed
3 hours ago
- #uveal melanoma
- #liver metastases
- #TIL therapy
- Phase I trial (HAITILS trial) evaluates locoregional administration of autologous tumor-infiltrating lymphocytes (TILs) via hepatic arterial infusion (HAI) in uveal melanoma patients with liver metastases.
- Uveal melanoma is a rare subtype with liver-dominant metastasis and poor response to immunotherapies.
- TIL therapy was manufactured using the CliniMACS Prodigy platform and administered with preconditioning chemotherapy (melphalan) and interleukin-2 (IL-2).
- Primary endpoint: Safety and feasibility; secondary endpoints: Clinical efficacy and TIL production feasibility.
- Results: No HAI-related adverse events (AEs); all patients experienced grade ≥3 hematologic AEs from chemotherapy. Best response was stable disease (100%). Median progression-free survival: 4 months; overall survival: 14 months.
- Conclusion: HAI TIL administration is safe and feasible but insufficient for durable efficacy, warranting further testing.